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临床试验/NCT02826707
NCT02826707已完成不适用

Feasibility Evaluation of a Smartphone-delivered Peer-led Physical Activity Counselling Program for Improving Physical Activity in Manual Wheelchair Users

Laval University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Objective physical activity

研究概览

简要总结

Despite physical activity (PA) being a valuable modality for promoting health, the evidence for effective PA intervention strategies for manual wheelchair (MWC) users is underdeveloped. Community-based programs and telephone-counselling interventions to increase PA among MWC users have had some success, but the uptake and adherence to these interventions remains low within this population. Community-based programs may not reach MWC users who live in rural areas and have issues with transportation, while health professionals may not optimally relate with MWC when providing telephone counselling. Although the PA needs of MWCs are not fully understood, there is reason to believe that including peers into intervention delivery may have benefits.

A feasibility trial is critical and prudent prior to moving forwards with a large and expensive multi-site randomized controlled trial (RCT) to ensure that: the intervention meets the needs of the target population; the right outcomes are measured; and that the intervention is feasible to administer.

The objective of this study is to evaluate the feasibility of a Smartphone-delivered Peer-led Physical Activity Counselling (SPPAC) program for MWC users.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •live in the community
  • •have used a manual wheelchair for ≥ 1 year
  • •able to self-propel a manual wheelchair for at least 10m
  • •able to communicate in English or French
  • •have physical activity or mobility goals
  • •cognitively able to set goals (Mini-mental State Exam Score ≥ 25)

排除标准

  • •anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
  • •have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic Lateral Sclerosis
  • •are concurrently or planning to receive manual wheelchair mobility training over the period of the study

研究组 & 干预措施

SPPAC intervention

Experimental

Smartphone-delivered peer-led physical activity counselling

干预措施: SPPAC intervention (Behavioral)

Control group

No Intervention

Pragmatic no-contact control group

结局指标

主要结局

Objective physical activity

时间窗: Change in physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention

Physical activity will be measured objectively using Actigraphy, a small, lightweight accelerometry-based tri-axial activity monitor (Actigraph 3GTX) that is worn on the wrist and MWC without impeding bodily movements or PA. Information about motion direction and speed are integrated to produce an electrical current with variable magnitude and duration. The electrical current data are stored in the monitor as 'activity counts.'

次要结局

  • Subjective physical activity (Leisure-Time Physical Activity Questionnaire (LTPA))(Change in LTPA from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Measure the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities (Reintegration to Normal Living Index - RNLI)(Change in RNLI from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Satisfaction of psychological needs (Psychological Need Satisfaction in Exercise Scale (PNSES))(Change in PNSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Measure of self-efficacy in performing functional activities of daily living in individuals with Spinal Cord Injury (Moorong Self Efficacy Scale - MSES)(Change in MSES from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Physical activity motivation (Behavioural Regulation in Exercise Questionnaire (BREQ-2))(Change in BREQ-2 from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Self-efficacy to overcome barriers to leisure-time physical activity (Leisure-time Physical Activity Barrier Self-efficacy Scale)(Change in Self-efficacy to overcome barriers to leisure-time physical activity from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Perceived autonomy support (Health Care Climate Questionnaire (HCCQ))(Change in HCCQ from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Wheelchair skills capacity and performance (Wheelchair Skills Test- Questionnaire (WST-Q))(Change in WST from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Wheelchair use self-efficacy (Wheelchair Use Confidence Scale Short Form (WheelCon-SF))(Change in WheelCon-SF from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)
  • Satisfaction with participation in physical activity using a wheelchair (Wheelchair Outcome Measure (WhOM))(Change in WhOM from baseline to post-intervention (10 weeks post-baseline) and at follow-up (3 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Krista Best

Assistant Professor/ Researcher

Laval University

研究点 (1)

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